Kornimate/medical-research-clean huggingface dataset:
usefulness of the chronic obstructive pulmonary disease-population (copd-ps) questionnaire and the copd-6 device in the chronic obstructive pulmonary disease detection in a tobacco detoxication consultation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to evaluate the usefulness of the chronic obstructive pulmonary disease-population questionnaire (copd-ps) and the copd-6 device in the early detection of chronic obstructive pulmonary disease in smoker patients .


Eligibility criteria:
inclusion criteria: * \> 35 years old * accumulative tobacco rate \> 10 paq-year that go to the tobacco detoxication consultation exclusion criteria: * unable to fulfill the questionnarie * unable to adequately perform the copd-6 or forced spirometry maneuvers included in the study. * reject to participate and sign the informed consent.

Keywords: chronic obstructive pulmonary disease copd chronic obstructive pulmonary disease population questionnaire copd-ps copd-6
a study of proquad™ in healthy children in korea (v221-023)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: this study will compare proquad™ and concomitant administration of m-m-r™ ii and varivax™ with respect to immunogenicity, safety and tolerability. the primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with proquad™ will be non-inferior to the antibody response rates after vaccination with concomitant m-m-r™ ii and varivax™.


Eligibility criteria:
inclusion criteria: * subject is in good health * subject has a negative clinical history for measles, mumps, rubella, varicella and zoster exclusion criteria: * subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination * subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity * subject has a history of seizure disorder * subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks * subject has received an inactivated vaccine within the past 14 days * subject has received a live vaccine within the past 30 days * subject has received immune globulin within the past 5 months * subject has a recent history of fever (within the last 72 hours)

Keywords: measles mumps rubella varicella
cardiovascular effects of selective i(f)-channel blockade

Conditions: Postural Orthostatic Tachycardia Syndrome

Summary: the study compares three treatment modalities in a human model of postural orthostatic tachycardia syndrome (pots): beta-blockers, i(f)-blockers, and placebo.

elevated heart rate may lead to cardiac disease in the long-term. therefore, drugs lowering heart rate are useful. beta-blockers are an established treatment modality. they not only lower heart rate but also contractility, which might be undesirable in certain tachycardic disorders. postural orthostatic tachycardia syndrome (pots) patients complain about dizziness, weakness, headache, lightheadedness, fatigue, nausea, and presyncope. in some patients there is elevated heart rate even during supine rest. in pots patients it is preferable to lower heart rate without reducing cardiac contractility which can be achieved by using so-called i(f)-blockers. thus, they might be superior to beta-blockers in pots. in our study, we artificially generate pots in healthy male subjects for about 48 hours. we want to compare the cardiovascular effects and orthostatic tolerance of the following treatments: beta-blocker, i(f)-blocker, and placebo. moreover, we will quantify changes in cardiovascular autonomic regulation brought about by i(f)-blockade versus placebo.

Eligibility criteria:
inclusion criteria: * healthy male * age 18-40 years * bmi: 18-30 kg/m² * arterial blood pressure \<=160/100 mm hg * co-operativity * voluntariness exclusion criteria: * conditions in which treatment might be ineffective or insecure * co-medication within the last 4 weeks * participation in another clinical trial within the last 4 weeks * unability to understand the study's aim * drug or alcohol abuse * secondary hypertension * creatinine \> 130 μm (1.47 mg/dl) * got/gpt \> 2 times normal * ggt \> 3 times normal * contraindications against reboxetine, beta-blocker, ivabradine * asthma, psoriasis * diabetes * heart failure (nyha iii or iv) * coronary artery disease * peripheral occlusive disease * cerebrovascular disease * ventricular extrasystoles (lown iii-v) * atrial fibrillation * resting heart rate \<60/min * neurologic/psychiatric disorder * pulmonary hypertension * dysthyroid metabolism

Keywords: pots
success tracking study

Conditions: Obesity

Summary: the overall purpose of this research is to evaluate the long-term outcomes associated with participation in medifast direct and take shape for life weight-loss programs in comparison with non-medifast weight-loss programs. another important goal of this research is to determine whether the differences between medifast direct and take shape for life programs affect weight-loss and maintenance of weight-loss in customers.

researchers desire to capture the behaviors and outcomes of those individuals who would enroll in these programs without the additional encouragement to be a participant in a research study. the study will employ an observational prospective design intended to introduce as little interference as possible with subjects' behaviors. this is in order to capture the pure effects of the weight-loss programs themselves, and to reduce the potentially confounding effects of merely participating in a research study. subjects who have already committed to a weight-loss program (medifast direct, take shape for life , or other) will be recruited to join this study, and will be asked to complete several questionnaires over a period of up to 6 ⅓ years after enrollment. questionnaires will measure information regarding anthropometrics, sociodemographics, and health \& quality of life outcomes. the overall goal of this research is to be able to describe and compare the long-term dieting behaviors and outcomes among participants in medifast direct and take shape for life programs in comparison with other dieters.

Eligibility criteria:
inclusion criteria: * adult males and females between the ages of 18 - 69 years * bmi ( \> 25.0 kg/m2) * beginning a weight loss diet plan (md, tsfl, or one of a number of commercially available plans)note: subjects must have already committed to a weight-loss plan in order to be eligible for this study. the recruitment process is specifically designed so as not to appear to encourage subjects to begin a weight-loss plan. rather, the purpose of this research is to track information about persons who have already committed to a weight-loss program. * willing and able to give informed consent * willing and able to comply with study protocol exclusion criteria: * unable to give informed consent * previous hospitalization for psychiatric disorder or eating disorder * current, uncontrolled medical conditions * taking unstable doses of weight-loss or appetite-affecting medications (e.g., ssris, steroids, ritalin) * taking prescription weight-loss drugs (phentermine, sibutramine, orlistat, etc...) * have undergone, or plan to undergo, weight loss surgery (e.g. gastric bypass, lap band, duodenal switch) in the next 6 1/3 years * plan to undergo weight-altering cosmetic surgery procedures (e.g. breast reduction/augmentation, tummy tuck, liposuction, or other skin removal procedures) in the next 6 1/3 years

Keywords: obesity weight loss meal replacements
retrospective survey of hyperkalemia in hemodialysis

Conditions: Hemodialysis Complication

Summary: this study aim to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on hd facility level.

this study is an observational survey study. we estimate 300 hemodialysis (hd) centres will be enrolled in the study. summarized data on serum potassium (sk) after long interdialytic interval (lidi), facility practice pattern and patient characteristics which may be related with sk management, and death records information including number of deaths for each centre will be collected. all the data collected and analysed are on hd facility level, not on patient-level. we are aiming to describe hyperkalemia clinical burden and investigate the risk factors associated with the burden on hd facility level. association between sk management and long-term outcome will also be explored.

Eligibility criteria:
inclusion criteria: - for hd centers: * ≥ 100 patients under mhd within 3 years prior the study initiation * willing to participate in the study * have routine blood collection after lidi * have death records for hd patients: • on chronic hd for ≥ 3 months exclusion criteria: * blood test on other days than those after lidi * unable to provide detailed data required by study protocol * being unable to comply with study-specified procedure
vaginal postpartum pain management protocol comparison

Conditions: Pain; Post Partum Depression; Opioid Use; Breast Feeding

Summary: untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. in this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

more than two million women deliver vaginally every year in the united states (us). along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement. a stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. the first step includes non-opioid analgesics (as paracetamol and nsaids), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine). in this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.

Eligibility criteria:
inclusion criteria: 1. women following term vaginal delivery. exclusion criteria: 1. under age 18 years or older than 45 years. 2. women with chronic pain syndrome. 3. women with relative or absolute contraindications for paracetamol or nsaids.
a study of erlotinib (tarceva) in participants with resected head and neck squamous cell cancer

Conditions: Head and Neck Cancer

Summary: this two-arm study will compare the efficacy and safety of erlotinib (tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (po) once daily or placebo for 1 year until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age * curatively treated head and neck squamous cell cancer with t3-t4 and/or n2-n3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement * eastern cooperative oncology group (ecog) status of 0 to 2 exclusion criteria: * macroscopic residual disease after surgery * previous treatment with anti-epidermal growth factor receptor (anti-egfr) targeted therapies
the effect of cannabis on pain and related quality of life outcomes in chronic pain: a prospective open-label study

Conditions: Chronic Pain

Summary: the objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.

this is a prospective, observational, open-label study carried out at the ambulatory pain clinic of hadassah-hebrew university medical center pain relief unit. study population: patients suffering from chronic pain that has not been relieved with other analgesic medications, who are eligible for treatment with medical cannabis (cigarettes, oil or cookies) following approval of israeli ministry of health.the patients will receive a prescription to be dispensed at pre-approved cannabis distribution points by a certified provider. in this study, the efficacy of the cannabis treatment on pain and related quality of life (qol) outcomes will be assessed by administering the s-tops questionnaire (haroutiunian, pain 2012), and the brief pain inventory (bpi) before the treatment (baseline), and on expected follow-up visits at approximately 6 and 12 months.

Eligibility criteria:
inclusion criteria: * age \>18 years old * chronic pain, with duration of 3 months or longer * lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose. exclusion criteria: * inability to read and understand the informed consent form. * history of drug abuse/dependence * psychiatric co morbidity (or history) of schizophrenia or acute psychosis. * family history of schizophrenia. * psychologist evaluation of high abuse risk.

Keywords: chronic pain cannabis approved for cannabis treatment by israeli ministry of health unrelieved chronic pain
rfn-advanced retrograde femoral nailing system

Conditions: Femur Fracture

Summary: this study is a retrospective chart review of the safety and performance standard of care data on individuals that have previously been implanted with the femur nail of the rfna system for the internal fixation of the femur. demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. descriptive statistics were applied to the data collected.


Eligibility criteria:
inclusion criteria: 1. subjects 18 years or older at the time of index procedure 2. subjects who received the depuy synthes advanced retrograde nail in accordance with the indications for use. 3. subjects who have at least 6 months of follow-up. exclusion criteria: * subject with less than 6 months of follow up, pathologic fractures, and patients \< 18 years of age will be excluded from the study.

Keywords: intramedullary nail retrograde union
ibrutinib and pd-1 blockade in high risk lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the impact of sequential overlapping treatment with pd-1 monoclonal antibody (mab), pembrolizumab/mk-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk cll patients. immune function will be evaluated through various laboratory correlative tests.


Eligibility criteria:
inclusion criteria: * have high risk cll * have documented previously untreated cll according to iwcll criteria * willing and able to provide written informed consent * eastern cooperative oncology group (ecog) performance status of 0 or 1 * demonstrate adequate organ function * able to take oral medication and willing to adhere to the medication regimen exclusion criteria: * currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment * meets iwcll criteria to start therapy * has had any treatment for cll including any investigational agent, chemotherapy, mab, anti-pd-1, anti-pdl-1, or anti-ctla-4 * transformation of cll to aggressive nhl (richter's transformation or pro-lymphocytic leukemia) * known active central nervous system (cns) metastases and/or carcinomatous meningitis * is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment * major surgery or a wound that has not fully healed within 4 weeks of first dose * additional criteria may apply

Keywords: lymphocytic leukemia cll blood disease white blood cells bone marrow disease immunotherapy
the impact of neut during potassium chloride replacement on pain and incidence of phlebitis

Conditions: Hypokalemia

Summary: the purpose of this study is to examine the impact of 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy for adult patients in a medical/surgical unit. using a randomized controlled double blinded experimental study design, patients who are 21 years or older are alert, awake, and oriented at the time of enrollment and have been ordered peripheral intravenous potassium chloride replacement will be recruited from one medical/surgical during the first 24-48 hours of their admission.

the specific aim of the study is: aim 1: to compare patient outcomes (phlebitis, pain at peripheral iv insertion site, frequency of changing iv access, and time for administration) between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups. aim 2: to compare number and type of nursing interventions done during peripheral intravenous potassium chloride replacement therapy between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups. aim 3: to compare attrition rates and reasons between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Eligibility criteria:
inclusion criteria: * admitted to the medical/surgical unit within the last 24 to 48 hours * awake, alert, and oriented times three * 21 years old and greater * receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or arnp as part of care and regardless of research * potassium level of 3.5 mmol/l or less. exclusion criteria: * patients who have been in the medical/surgical unit more than 48 hours. * altered mental status defined as not being awake, alert, and oriented times three * patients who already received intravenous potassium chloride replacement during the current admission and with the current iv access * patients receiving intravenous potassium replacement therapy through a central line * patients that are not ordered potassium replacement by physician or arnp as part of their care while hospitalized.
synergistic effects of anxiety and alcohol use among latinos and its sociocultural mechanisms

Conditions: Alcohol Drinking; Racism

Summary: the purpose of this study is to examine the pharmacological effects of alcohol on acute anxiety levels in a sample of latino drinkers, and cultural experiences influencing these relationships.


Eligibility criteria:
inclusion criteria: 1. 21-65 years of age 2. moderate or heavy drinker based on a past-month audit score \>= 8. exclusion criteria: 1. possibility of being pregnant (verified by urine sample); 2. self-reported history of or treatment for alcohol/other drug problems (as required by the irb in past human alcohol administration research); 3. moderate risk for drug problems as indicated by smast scores ≥ 5 or assist scores of ≥ 4 (see measures); 4. medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease); 5. current use of psychiatric meds or any meds with alcohol contraindication (e.g., antibiotics); 6. current non-alcohol substance use disorder; 7. active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.
yoga@work intervention to reduce work-related stress among information technology workers

Conditions: Occupational Stress; Psychological Stress

Summary: over the last several decades, occupational stress at workplace comprise a major burden. office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. workplace wellness programs has been very feasible access to employees at their own convenience and need. yoga@work program was developed to suit the need for information technology workers.


Eligibility criteria:
inclusion criteria: * information technology employee, or trainee willing and able to participate in a 6-week self-care program during the work day. * willing to give informed consent exclusion criteria: * medical or psychiatric conditions limiting practice of yoga in general * cognitive impairment
effects of combined treatment with tdcs and cognitive training in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: chronic pain represents an important health problem responsible for decreases in quality of life, and is associated with great negative impact in society and economy. in many cases, its treatment does not reach therapeutic success causing health professionals and patients dissatisfaction. chronic pain is also associated with somatization, hopelessness and catastrophizing thinking. these information processing includes sensorial, emotional and cognitive-appraisal thinking, which manifests the working of neural networks at cortical and sub-cortical levels. attention and memory are a central aspect in the processing of pain modulation. like in addictions (e.g. smoking, alcohol), chronic pain may debut with displacement in the focus of attention and alterations in the sensorial processing in the incentive-motivation tests. considering that other studies have indicated that experimental and clinical pain is capable of modulating cognitive activities such as attention,memory and expectation, in this study the investigators will test whether cognitive training, tdcs, or the combination of both interventions decrease cognitive deficits associated with fibromyalgia

will be included women aged between 18 and 65 years, chronic pain fibromyalgia according to the criteria of the american college of rheumatology, pain unresponsive to analgesics such as paracetamol, acetylsalicylic acid, ibuprofen, carisoprodol, zanaflex (tizanidine) and codeine and give informed consent to participate after initial evaluation. primary outcome is to evaluate whether the tdcs associated with cognitive retraining technique is able to modulate attentional bias in fibromyalgia patients. secondary outcomes are: compare the effect of active tdcs and sham in: assessed with the visual analog scale for 8 days, functional capacity, conditional pain modulation (cpm), maximal heat pain tolerance,catastrophic thinking,serum levels of brain derived neurotrophic factor (bdnf), beck depression inventory, forward and backward digit span( wais),pittsburgh sleep quality and state-trait anxiety inventory (stai) test.

Eligibility criteria:
inclusion criteria: * female patients * literate * right-handed * 18 to 65 years of age * who meet the criteria of the american college of rheumatology (acr) for fibromyalgia. exclusion criteria: * pregnant women * contraindications to tdcs * metal implant in the brain * history of alcohol or drug abuse in the last six months * history of neurological disorders * unexplained fainting * self-reports of head injury or momentary loss of awareness * neurosurgery. * will also be excluded patients who have decompensated systemic diseases and / or chronic inflammatory diseases (ex .: lupus, rheumatoid arthritis).

Keywords: attention memory (short and long-term) conflict monitoring tasks verbal fluency